Study of the Effect of Glutamine Supplementation on Chemotherapy Induced Toxicities in Breast Cancer Patients
NCT ID: NCT00772824
Last Updated: 2018-07-17
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
PHASE4
23 participants
INTERVENTIONAL
2007-12-31
2009-12-31
Brief Summary
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
PREVENTION
SINGLE
Study Groups
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1
10 patients (30 cycles) of chemotherapy will receive placebo
No interventions assigned to this group
2
Intravenous glutamine
IV Glutamine
50 ml of 20% glutamine IV before chemotherapy
3
Oral Glutamine
Glutamine
2g/kg body weight twice daily in divided doses for 5 days
Interventions
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Glutamine
2g/kg body weight twice daily in divided doses for 5 days
IV Glutamine
50 ml of 20% glutamine IV before chemotherapy
Eligibility Criteria
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Inclusion Criteria
* Histologically or cytologically proven breast cancer
* Receiving CEF chemotherapy cycles presently or in the past
* The patients who will give informed consent to participate in the study
* Patients must have sufficient organ and marrow function
* Stage 1 neuropathy, subclinical neuropathy, surgery induced neuropathy
Exclusion Criteria
* Clinical/biochemical severe liver failure
* Clinical/biochemical severe renal dysfunction
* Refusal to participate in the study
* Patients who have received prior chemotherapy with paclitaxel.
* Patients who have neuropathy due to any known systemic or metabolic causes like diabetes, leprosy, nutritional deficiency induced (vit. B12) etc
18 Years
85 Years
FEMALE
No
Sponsors
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Banaras Hindu University
OTHER
Responsible Party
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Manoj Pandey
Professor, Surgical Oncology
Principal Investigators
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R K Goel, MD
Role: PRINCIPAL_INVESTIGATOR
Institute of Medical Sciences
Locations
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Sir Sunder Lal Hospital
Varanasi, Uttar Pradesh, India
Countries
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References
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Rubio IT, Cao Y, Hutchins LF, Westbrook KC, Klimberg VS. Effect of glutamine on methotrexate efficacy and toxicity. Ann Surg. 1998 May;227(5):772-8; discussion 778-80. doi: 10.1097/00000658-199805000-00018.
Satoh J, Tsujikawa T, Fujiyama Y, Bamba T. Nutritional benefits of enteral alanyl-glutamine supplementation on rat small intestinal damage induced by cyclophosphamide. J Gastroenterol Hepatol. 2003 Jun;18(6):719-25. doi: 10.1046/j.1440-1746.2003.03042.x.
van der Hulst RR, van Kreel BK, von Meyenfeldt MF, Brummer RJ, Arends JW, Deutz NE, Soeters PB. Glutamine and the preservation of gut integrity. Lancet. 1993 May 29;341(8857):1363-5. doi: 10.1016/0140-6736(93)90939-e.
Govindarajan R, Heaton KM, Broadwater R, Zeitlin A, Lang NP, Hauer-Jensen M. Effect of thalidomide on gastrointestinal toxic effects of irinotecan. Lancet. 2000 Aug 12;356(9229):566-7. doi: 10.1016/s0140-6736(00)02586-1.
Bergstrom J, Furst P, Noree LO, Vinnars E. Intracellular free amino acid concentration in human muscle tissue. J Appl Physiol. 1974 Jun;36(6):693-7. doi: 10.1152/jappl.1974.36.6.693. No abstract available.
Lacey JM, Wilmore DW. Is glutamine a conditionally essential amino acid? Nutr Rev. 1990 Aug;48(8):297-309. doi: 10.1111/j.1753-4887.1990.tb02967.x.
Daniele B, Perrone F, Gallo C, Pignata S, De Martino S, De Vivo R, Barletta E, Tambaro R, Abbiati R, D'Agostino L. Oral glutamine in the prevention of fluorouracil induced intestinal toxicity: a double blind, placebo controlled, randomised trial. Gut. 2001 Jan;48(1):28-33. doi: 10.1136/gut.48.1.28.
Berthrong M. Pathologic changes secondary to radiation. World J Surg. 1986 Apr;10(2):155-70. doi: 10.1007/BF01658133. No abstract available.
Huang EY, Leung SW, Wang CJ, Chen HC, Sun LM, Fang FM, Yeh SA, Hsu HC, Hsiung CY. Oral glutamine to alleviate radiation-induced oral mucositis: a pilot randomized trial. Int J Radiat Oncol Biol Phys. 2000 Feb 1;46(3):535-9. doi: 10.1016/s0360-3016(99)00402-2.
Cao Y, Kennedy R, Klimberg VS. Glutamine protects against doxorubicin-induced cardiotoxicity. J Surg Res. 1999 Jul;85(1):178-82. doi: 10.1006/jsre.1999.5677.
Boyle FM, Wheeler HR, Shenfield GM. Amelioration of experimental cisplatin and paclitaxel neuropathy with glutamate. J Neurooncol. 1999 Jan;41(2):107-16. doi: 10.1023/a:1006124917643.
Vahdat L, Papadopoulos K, Lange D, Leuin S, Kaufman E, Donovan D, Frederick D, Bagiella E, Tiersten A, Nichols G, Garrett T, Savage D, Antman K, Hesdorffer CS, Balmaceda C. Reduction of paclitaxel-induced peripheral neuropathy with glutamine. Clin Cancer Res. 2001 May;7(5):1192-7.
Other Identifiers
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GLU_07
Identifier Type: -
Identifier Source: org_study_id
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